MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	67P040
Medical Device Problem Codes	Deflation Problem (1149); Overfill (2404); Failure to Deflate (4060)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that when attempting to deflate the cuff of the tracheostomy tube, it took 3-4 attempts to get all the water out.Only 2ml of the 2.4ml that was used to inflate balloon was able to be taken out.A trach change was done to determine what the issue was.The pilot balloon was completely deflated and when the tube was taken out the cuff was found overinflated.Pulling the trach tube out in the inflated state caused bleeding.The patient was taken to the hospital for observation to make sure there was no damage to the airway.This is not the first of this type of issue.There have been 5 such issues with this one leading to patient injury.
Additional Manufacturer Narrative
Email is: regulatory.Responses@icumed.Com.Three device samples were received in used condition without original packaging.Two samples were for part number 67p040 and one sample of a different part number, the part number of the different sample was not reported.Per visual inspection, sample one has no visual conditions, sample two shows signs of use and stains inside the cuff, sample three is a part number that does not have a cuff.Per functional testing, samples one and two were inflated and deflated without problems with the support of a syringe.The complaint was not confirmed, and no further analysis was performed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No corrective actions were taken since the complaint was not confirmed.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16602015
• Report Number: 3012307300-2023-02983
• Device Sequence Number: 7324934
• Product Code: JOH
• UDI-Device Identifier: 15021312006278
• UDI-Public: 15021312006278
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 67P040
• Device Catalogue Number: 67P040
• Device Lot Number: 4273415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 MO
• Patient Sex: Male
• Patient Weight: 11 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White